Clinical Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients

Initiator Pharma

Status and phase: Enrolling; Phase 2

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo; Drug: IP2018

Study type: Interventional

Funder types: Industry

Identifiers

NCT04686916

IP2018CS01

Details and patient eligibility

About

This is a Phase IIa, randomised, double-blind, placebo-controlled, 3-period, crossover study to assess two single oral dose levels of IP2018. It is planned to enrol 24 patients. Patients will take part in three treatment periods, in which they will be randomised to receive either a single dose of IP2018 or a single dose of placebo in each treatment period.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients with a diagnosis of mild to moderate depression and ED as determined from the Hamilton depression scale score of 7 to 23 and International Index of Erectile Function (IIEF-5) score of 12 to 18, respectively, with a body mass index of 18 to 32 kg/m2 (inclusive), of any ethnic origin.

Exclusion criteria

• Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), haematological, endocrinological, metabolic, neurological, psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of Investigator, may place the patient at unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

IP2018_dose 1

Experimental group

Description:

IP2018_dose1

Treatment:

Drug: IP2018

IP2018_dose 2

Experimental group

Description:

IP2018_dose2

Treatment:

Drug: IP2018

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo